To evaluate long-term efficacy and safety of the SmartPlug in the management of severe dry eye syndrome.A retrospective chart review was conducted of patients who underwent SmartPlug insertion from June 2003 to December 2005. The clinical data collected included sex and age of the patients, indications for plug insertion, Schirmer tear function test with anesthesia, frequency of lubricant eye drop use before and after plug insertion, fluorescein staining at baseline and at last follow-up, and complications.There were 91 eyes of 54 patients (44 women and 10 men) in the study group. The average follow-up period was 13.0 +/- 6.0 months, with a minimum of 6 months. Thirty patients (55 eyes, 60.4%) reported a decreased use of lubricant eye drops after SmartPlug insertion, including 9 patients (14 eyes, 15.4%) who were free of supplementary lubricant eye drops. Forty-one patients (69 eyes, 75.8%) reported subjective symptom improvement after SmartPlug insertion. The corneal fluorescein staining showed overall reduction. Complications included canaliculitis (6 eyes, 6.6%), epiphora requiring plug removal (5 eyes, 5.5%), and spontaneous plug loss (2 eyes, 2.2%).SmartPlug can be effective in the management of severe dry eye syndrome. However, long-term follow-up is needed for potentially serious complications such as canaliculitis.